Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i as Triple Therapy With Type 2 Diabetes and Chronic Kidney Disease
Trial Parameters
Brief Summary
To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or above * Diagnosis of type 2 diabetes at least 6 months * CKD (eGFR by CKD-EPI 25-90 ml/min/1.73m2 with uACR 30 to \<300 mg/g) and/or those with severely elevated albuminuria (uACR 30-5000 mg/g) and eGFR \> 60 ml/min/1.73m2. * Patients should have a serum potassium \<4.8 mmol/l at screening * On SGLT2i (dapagliflozin or empaglifozin) at screening at stable doses for at least 4 weeks. * On ACEi or ARB at maximum tolerated dose per manufacturer's label that did not cause unacceptable side effects * In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate. Exclusion Criteria: * Type 1 diabetes * Allergy, contraindications or intolerance to ACEi/ARB * Contraindications or intolerance to mineralocorticoid receptor antagonists * Allergy, contraindications to SGLT2is * Currently pregnant